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Novel Imaging Agents to Expand the Clinical Toolkit for Cancer Diagnosis, Staging, and Treatment



Medical imaging plays a key role in clinical management of cancer patients. Cancer imaging agents are used in conjunction with medical imaging equipment, and, by highlighting the contrast between normal and malignant tissues, they allow the collection of information on cancer presence, spread, and metabolism.

Recent scientific advances in nanotechnology, radiochemistry, reporter gene imaging, cancer stem cell imaging, and other fields now enable the development of novel imaging agents for:

·       Early detection and diagnosis of cancer

·       Differentiation of benign disease from malignancy

·       Stratification of patients for the purpose of selecting a cancer therapy

·       Surgical planning

·       Evaluation of tumor response to chemotherapy and radiation therapy

·       Detection of cancer recurrence

However, despite significant preclinical scientific progress, very few cancer imaging agents are actually available in the clinic. Therefore, this SBIR contract topic seeks to stimulate the commercialization of novel imaging agents, including: nanotechnology-based imaging agents, radiopharmaceuticals for positron emission tomography (PET) and single photon emission computed tomography (SPECT), targeted contrast agents for X-ray, computed tomography (CT), and magnetic resonance imaging (MRI), optical contrast agents, and reporter gene imaging technologies.

One specific area of interest under this topic is the development of single-domain antibody fragments used to target radionuclides for imaging and targeted radiotherapy of cancer. Single-domain antibody fragments comprise the single variable region of naturally-occurring antibodies that lack a light chain or engineered antibody fragments. This type of small protein or peptide has advantages over conventional antibodies and antibody fragments in terms of favorable and tunable clearance kinetics, ability to recognize hidden or uncommon epitopes, agent format flexibility, and ease of manufacture. Therefore, developing an imaging technology for early diagnosis of cancer at the molecular level based on single domain antibody fragments will be encouraged.

Project goals:

The short-term goal of this SBIR contract topic is to support research and development activity at small businesses that are developing cancer imaging agents. The imaging agent should be novel and, when appropriate, have high affinity and specificity against tumor targets. It should also display fast in vivo clearance, rapid tumor accumulation, sufficient in vivo stability and good biovailability, and low immunogenicity and toxicity. The work scope may include animal testing, formulation, GMP production, pharmacokinetic studies, pharmacodynamic studies, and toxicological studies. These data will support the rationale for continued development of the experimental medical imaging agent to the point of filing an Investigational New Drug application (IND).

The long-term goal of this contract topic is to enable small businesses to bring novel classes of fully developed cancer imaging agents to the clinic and the market. Therefore, businesses are encouraged to submit applications for development of lead compounds representing novel technology platforms.

Phase I Activities and Expected Deliverables:

Phase I activities should generate scientific data confirming the clinical potential of the proposed contrast agent. Some of the expected activities are:

·       Preparation ofan imaging agent.

·       Demonstration of capabilitiesenabled by the imaging agent with a high signal-to-noise ratio.

·       Quantification of the imagingsignals to determine the agent affinity and specificity.

·       Proof of concept pre-clinicalstudies.

·       Preliminary toxicologicalstudies.

·       Preparation of a development plan that describes in detail the experiments necessary to file an IND or an exploratoryIND.

·       Presentationof the Phase I results and the development plan to NCI staff.

The Phase I research plan must contain specific, quantifiable, and testable feasibility milestones.

Phase II Activities and Expected Deliverables:

Phase II should follow the development plan laid out in the Phase I, and should further support commercialization of proposed cancer imaging agents. Some of the expected activities are:

·       Completionof all pre-clinical experiments according to the development plan.

·       Demonstration of fast in vivo clearance, rapid tumor accumulation, sufficient in vivo stability, good bioavailability, and low immunogenicity/toxicity.

·       Demonstrationof high reproducibility and accuracy of the imaging technology in several animal models.

·       When appropriate, demonstration of similar or higher specificity and sensitivity of the technology when compared to other imaging technologies.

·       When appropriate, demonstration of capabilities to monitor efficacy of drugs in tumor cell lines and/or animals.

·       Productionof sufficient amount of clinical grade material suitable for an early clinical trial.

·       If warranted, filing of an IND or an exploratory IND for the candidate imaging agent.

·       Completionof a small-scale clinical study.

The Phase II research plan must contain specific, quantifiable, and testable feasibility milestones.

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